Regeneron Reports Second Quarter 2026 Financial and Operating Results

On July 30, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the second quarter of 2026 and provided a business update.

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"Regeneron delivered another quarter of strong financial performance, with double-digit top- and bottom-line growth reflecting the continued strength of our commercial portfolio and the potential of our pipeline," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "Of note, global Dupixent, global Libtayo, and U.S. EYLEA HD net product sales increased by 38%, 30%, and 52%, respectively, compared to the second quarter of 2025. With approximately 50 clinical assets, we remain focused on translating our science into even more successful new medicines across a broad array of diseases."
Financial Highlights

($ in millions, except per share data) Q2 2026 Q2 2025 % Change
Total revenues $ 4,291 $ 3,676 17 %
GAAP net income $ 1,297 $ 1,392 (7 %)
GAAP net income per share – diluted $ 12.23 $ 12.81 (5 %)
Non-GAAP net income(a)
$ 1,543 $ 1,424 8 %
Non-GAAP net income per share – diluted(a)
$ 14.29 $ 12.89 11 %

"Second quarter revenues grew 17% and non-GAAP net income per share grew 11%, marking our second consecutive quarter of double-digit growth on both measures," said Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "By the end of the second quarter, we had fully repaid the Sanofi Development Balance, which represented the outstanding amount due to Sanofi for their funding of prior collaboration development activities. The repayment of this obligation will drive a meaningful step-up in collaboration profits beginning in the third quarter. Given our strong financial position, we continue to invest confidently in our pipeline, U.S. manufacturing, and external innovation, while returning capital to shareholders, reflected by the nearly $3.0 billion deployed in the first half of the year to share repurchases, dividends, capital expenditures, and business development."
Business Highlights
Key Pipeline Progress
Regeneron has approximately 50 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:
Dupixent (dupilumab)
•In April 2026, the U.S. Food and Drug Administration (FDA) and European Commission approved Dupixent for the treatment of chronic spontaneous urticaria (CSU), expanding the eligible population to include children aged 2 to 11 years who remain symptomatic despite antihistamine treatment.
EYLEA HD (aflibercept) 8 mg
•In April 2026, the FDA approved the extension of dosing intervals for EYLEA HD up to every 20 weeks (5 months) for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) following one year of successful response based on visual and anatomic outcomes.
Otarmeni (lunsotogene parvec, formerly known as DB-OTO)
•In May 2026, the European Medicines Agency (EMA) accepted for review, under accelerated assessment, the Marketing Authorization Application (MAA) for Otarmeni for the treatment of biallelic OTOF variant-associated hearing loss.
Fianlimab (LAG-3 antibody)
•In May 2026, the Company announced results from the Phase 3 trial evaluating two dose levels of fianlimab in combination with cemiplimab as a first-line treatment for patients with unresectable locally advanced or metastatic melanoma. The trial did not reach statistical significance for the primary endpoint of improvement in progression-free survival (PFS) compared to pembrolizumab monotherapy.
Other Programs
•In June 2026, the Company announced that both the FDA and EMA have accepted the regulatory applications for cemdisiran (C5 RNAi therapy) to treat adult patients with gMG. The FDA will review the New Drug Application (NDA) under priority review with a target action date in November 2026, following use of a Priority Review Voucher. A decision from the European Commission is anticipated in the second half of 2027.
•The Company announced positive results from the Phase 1/2 LINKER-AL2 trial for Lynozyfic (linvoseltamab) in adults with second-line-plus systemic amyloid light chain amyloidosis. The results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)

(ASCO) 2026 Annual Meeting. The Phase 2 portion of the trial with registrational intent, part of a broad clinical development program investigating Lynozyfic, is underway.
•A Phase 3 study was initiated in peripheral artery disease (PAD) for cenvacibart (REGN7508, an antibody to Factor XI (catalytic domain)), and amrecibart (REGN9933, an antibody to Factor XI (A2 domain)), to evaluate each antibody individually compared to standard of care.
Corporate Updates
•The FDA selected the Company’s manufacturing facility in Saratoga Springs, New York, which is currently under construction, to participate in the FDA PreCheck Pilot Program. The FDA PreCheck Pilot Program is intended to support the development of new U.S. pharmaceutical manufacturing facilities by encouraging earlier FDA engagement and providing a more predictable regulatory pathway.
•In May 2026, the Company entered into a collaboration with Parabilis Medicines to discover and develop multiple therapeutic candidates based on Parabilis’ Helicon peptide platform.
•The Company announced that it had been named to the Dow Jones Best-in-Class World Index, one of the world’s most recognized benchmarks for corporate sustainability performance, for the seventh consecutive year.
Second Quarter 2026 Financial Results
Revenues
($ in millions) Q2 2026 Q2 2025 % Change
Net product sales:
EYLEA HD – U.S. $ 596 $ 393 52 %
EYLEA – U.S.
412 754 (45 %)
Total EYLEA HD and EYLEA – U.S. 1,008 1,147 (12 %)
Libtayo – U.S. 343 248 38 %
Libtayo – ROW* 146 129 13 %
Total Libtayo – Global
489 377 30 %
Praluent – U.S.
75 66 14 %
Evkeeza – U.S.
53 41 29 %
Lynozyfic – Global
17 — **
Total net product sales 1,642 1,631 1 %
Collaboration revenue:
Sanofi 2,174 1,444 51 %
Bayer 276 415 (33 %)
Other 6 2 **
Other revenue 193 184 5 %
Total revenues $ 4,291 $ 3,676 17 %

Net product sales of EYLEA HD increased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to higher sales volumes driven by increased demand, partly offset by a lower net selling price.
Net product sales of EYLEA in the second quarter of 2026, compared to the second quarter of 2025, were negatively impacted by (i) lower sales volumes, driven by decreased demand, as a result of continued competitive pressures and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.
Global net product sales of Libtayo increased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to higher sales volumes driven by increased demand.
Sanofi collaboration revenue increased in the second quarter of 2026, compared to the second quarter of 2025, due to an increase in the Company’s share of profits from the commercialization of antibodies, which were $2.033 billion and $1.282 billion in the second quarter of 2026 and 2025, respectively. The change in the Company’s share of profits from the commercialization of antibodies was driven by higher profits primarily associated with an increase in Dupixent sales. In addition, the Sanofi Development Balance was fully repaid as of the end of the second quarter of 2026 and will no longer reduce Sanofi collaboration revenue beginning in the third quarter of 2026.
Refer to Table 4 for a summary of collaboration revenue.
Operating Expenses
GAAP % Change
Non-GAAP(a)
% Change
($ in millions)
Q2 2026 Q2 2025 Q2 2026 Q2 2025
Research and development (R&D) $ 1,632 $ 1,422 15 % $ 1,500 $ 1,283 17 %
Acquired in-process research and development (IPR&D) $ 127 $ 10 ** * * *
Selling, general, and administrative (SG&A) $ 662 $ 634 4 % $ 574 $ 542 6 %
Cost of goods sold (COGS) $ 361 $ 276 31 % $ 221 $ 222 — %
Gross margin on net product sales(b)
78% 83% 87% 86%
Cost of collaboration and contract manufacturing (COCM)(c)
$ 216 $ 255 (15 %) * * *
* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded
** Percentage not meaningful or greater than 100%

•GAAP and non-GAAP R&D expenses increased in the second quarter of 2026, compared to the second quarter of 2025, driven by the Company’s mid- and late-stage clinical pipeline.
•Acquired IPR&D expenses for the second quarter of 2026 included up-front and opt-in payments in connection with collaboration and licensing agreements.
•GAAP gross margin on net product sales decreased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to unabsorbed manufacturing costs as a result of the previously disclosed temporary interruption of bulk manufacturing production at the Company’s facility in Limerick, Ireland. As of the end of the second quarter of 2026, bulk manufacturing production returned to normal levels. The interruption did not impact the availability of any of the Company’s products.
Other Financial Information
GAAP other income (expense), net decreased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to lower net gains on marketable and other securities.
In the second quarter of 2026, the Company’s GAAP effective tax rate (ETR) was 15.1%, compared to 8.4% in the second quarter of 2025. The GAAP ETR increased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to the net change in unrecognized tax benefits, as during the second quarter of 2025 the Company released liabilities associated with unrecognized tax benefits upon the settlement of an IRS audit. In the second quarter of 2026, the non-GAAP ETR was 15.5%, compared to 8.3% in the second quarter of 2025.
A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.
Capital Allocation
During the three and six months ended June 30, 2026, the Company repurchased $1.2 billion and $2.0 billion, respectively, of its common stock. As of June 30, 2026, $2.5 billion remained available for share repurchases under the Company’s share repurchase programs.
In July 2026, the Company’s board of directors declared a cash dividend of $0.94 per share on the Company’s common stock and Class A stock, payable on August 31, 2026 to shareholders of record as of August 18, 2026.
2026 Financial Guidance*
The Company’s full year 2026 financial guidance consists of the following components:
2026 Guidance
Prior
Updated
GAAP R&D $6.450–$6.680 billion $6.500–$6.635 billion
Non-GAAP R&D(a)
$5.900–$6.100 billion $5.950–$6.050 billion
GAAP SG&A
$2.860–$3.040 billion $2.830–$2.960 billion
Non-GAAP SG&A(a)
$2.500–$2.650 billion $2.500–$2.600 billion
GAAP gross margin on net product sales
77%–78% 78%–79%
Non-GAAP gross margin on net product sales(a)
83%–84% 84%–85%
GAAP COCM
$955 million–$1.035 billion
$985 million–$1.035 billion
Non-GAAP COCM(a)
$940 million–$1.020 billion $970 million–$1.020 billion
Capital expenditures
$1.100–$1.200 billion
$1.030–$1.100 billion
GAAP effective tax rate 12%–14% 13%–14%
Non-GAAP effective tax rate(a)
13%–15% 14%–15%
* The Company’s 2026 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release

(Press release, Regeneron, JUL 30, 2026, View Source [SID1234669546])

Leads Biolabs’ Opamtistomig (PD-L1/4-1BB Bispecific Antibody) Completes Patient Enrollment in Phase II Study for Biliary Tract Cancer, Further Demonstrating Breakthrough Potential in Immune-Cold Tumors

On July 30, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that the Phase II clinical study of its core product Opamtistomig (LBL-024, a PD-L1/4-1BB bispecific antibody) for the treatment of first-line advanced biliary tract cancer (BTC) has completed enrollment of all 70 patients. In April 2026, the study successfully entered the expansion phase based on a favorable safety profile and robust efficacy that exceeded expectations, and rapidly completed full patient enrollment, fully demonstrating the efficient clinical advancement and continuously validated significant efficacy of Opamtistomig.

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Despite the recent adoption of PD-(L)1 immunotherapy combined with chemotherapy as a first-line standard of care for advanced BTC, clinical benefits remain limited. Current standard regimens, including pembrolizumab plus chemotherapy and durvalumab plus chemotherapy, have demonstrated objective response rates (ORR) below 30% and median overall survival (OS) of only approximately 12–13 months, leaving a substantial unmet medical need in this aggressive malignancy.

The potential of Opamtistomig as an IO 2.0 pan-tumor cornerstone therapy has been continuously validated across three dimensions: broad-spectrum anti-tumor activity, long-term survival benefit trends, and a safety profile comparable to PD-(L)1 monoclonal antibodies. Existing data show that, following extrapulmonary neuroendocrine carcinoma (EP-NEC) and small cell lung cancer (SCLC), Opamtistomig has once again demonstrated highly competitive efficacy in BTC, a typical immune-cold tumor, with the potential to elevate the efficacy of immunotherapy in BTC to new heights. Given that the predominant pathological type of BTC is adenocarcinoma, combined with the positive data previously observed in squamous cell carcinoma subtypes of major cancer types such as non-small cell lung cancer (NSCLC), Opamtistomig has shown clear efficacy in both adenocarcinoma and squamous cell carcinoma types, with its broad-spectrum anti-cancer potential being continuously validated.

The multicenter study is led by Academician Zhou Jian of Zhongshan Hospital, Fudan University and is being conducted across multiple hospitals in China. Results from safety run-in data showed that Opamtistomig in combination with chemotherapy demonstrated a favorable overall safety profile and good tolerability, with no new safety signals identified. Preliminary efficacy assessments showed an encouraging tumor shrinkage. Detailed clinical data will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting to be held in Madrid, Spain from October 23 to 27, 2026.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said: "The rapid progress of our Phase II BTC study reflects the strong confidence investigators and patients have placed in the encouraging efficacy signals generated by Opamtistomig to date. Immune-cold tumors remain among the greatest challenges in oncology and represent one of the most important frontiers for next generation immunotherapy. Across multiple immune-cold tumor types, Opamtistomig has consistently demonstrated promising clinical activity, further validating its potential as an IO 2.0 pan-tumor cornerstone therapy. We are committed to accelerating the clinical development of Opamtistomig in BTC and look forward to bringing a more effective and durable treatment option to patients with this devastating disease as early as possible."

About Biliary Tract Cancer
Biliary tract malignancies primarily include gallbladder cancer and intrahepatic/extrahepatic cholangiocarcinoma, with approximately 419,100 new cases globally in 2024. These malignancies are predominantly ‌adenocarcinomas‌ with high invasiveness, and most cases are diagnosed at advanced stages, leading to ‌poor prognosis‌ (5-year survival rate <5%)‌. Currently, global incidence of biliary tract malignancies is rising, with the highest prevalence observed in Asian countries.

Although ‌PD-1/L1 inhibitors combined with chemotherapy‌ have been approved as first-line treatment for advanced biliary tract malignancies, clinical benefits remain limited: ‌Modest improvement in median overall survival (OS)‌ (from ~11.5 to 12.8 months)‌ and ‌Low objective response rate (ORR)‌ (<30%)‌. These gaps highlight ‌unmet medical needs‌ for more effective therapies‌.

About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig is designed to simultaneously block PD-1/L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across four indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

As the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, Opamtistomig has been evaluated in 13 solid tumor indications in China, including 1 pivotal registration trial and 8 proof-of-concept studies. These cover EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), malignant melanoma, and other areas with high unmet medical needs.

Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors. Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

(Press release, Nanjing Leads Biolabs, JUL 30, 2026, View Source [SID1234669563])

Castle Biosciences Reports Second Quarter 2026 Results

On July 30, 2026 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the second quarter ended June 30, 2026.

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"The Castle Biosciences team delivered another outstanding quarter," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We believe our strong growth through the first half of 2026 demonstrates the clinical value our tests bring to patient care and the dedication of our talented team to deliver results so that our clinician customers and patients can act with confidence.

"Given this momentum, we are raising our 2026 total revenue guidance to $365-375 million, up from our previous range of $345-355 million. We also now expect to achieve positive Adjusted EBITDA for the third quarter, the fourth quarter and the full year 2026.

"We are also encouraged by an independent study supporting the clinical impact of AdvanceAD-Tx in guiding systemic treatment selection. At the Revolutionizing Atopic Dermatitis meeting in June, data from a multi-center study showed only 54.3% of patients receiving baseline systemic therapy were initially on pathway-concordant treatment; however, following testing with our AdvanceAD-Tx test, 97.8% of patients were initiated on molecularly concordant systemic therapy.

I want to thank the entire Castle team for their focus, commitment and disciplined execution, which continue to advance our mission of improving health through innovative tests that guide patient care."

Second Quarter Ended Jun. 30, 2026, Financial and Operational Highlights
•Revenues were $103.5 million, compared to $86.2 million in the second quarter of 2025. Affecting second quarter 2026 revenue was the change in DecisionDx-SCC Medicare coverage effective April 24, 2025, the re-focus of our commercial efforts, as well as the discontinuation of IDgenetix in May 2025.

Core revenue drivers:
•Second quarter 2026 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 32% over the second quarter of 2025:
◦DecisionDx-Melanoma test reports delivered in the quarter were 10,280, compared to 9,981 in the second quarter of 2025.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 14,988, compared to 9,170 in the second quarter of 2025.

Additional tests:
◦DecisionDx-SCC test reports delivered in the quarter were 4,011, compared to 4,762 in the second quarter of 2025.
◦MyPath Melanoma test reports delivered in the quarter were 1,061, compared to 1,166 in the second quarter of 2025.
◦DecisionDx-UM test reports delivered in the quarter were 482, compared to 468 in the second quarter of 2025.

•Gross margin was 75%, and Adjusted Gross Margin was 76%, compared to 77% and 80%, respectively, for the same periods in 2025.
•Net loss, which includes non-cash stock-based compensation expense of $11.6 million, was $2.1 million, compared to net income of $4.5 million for the same period in 2025.
•Net loss per share and Adjusted Net Loss per Share, Basic and Diluted, was $0.07, compared to net income per share and Adjusted Net Income per Share, Basic and Diluted, of $0.16 and $0.15, respectively, for the same period in 2025.
•Adjusted EBITDA was $12.4 million, compared to $10.4 million for the same period in 2025.
•Net cash provided by operations was $15.2 million, compared to net cash provided by operations of $20.8 million for the same period in 2025.

Six Months Ended Jun. 30, 2026, Financial and Operational Highlights
•Revenues were $187.2 million, compared to $174.2 million for the six months ended June 30, 2025. Affecting comparison to 2025 includes the change in DecisionDx-SCC Medicare coverage effective April 24, 2025, the re-focus of our commercial efforts, as well as the discontinuation of IDgenetix in May 2025.

Core revenue drivers:
•First half 2026 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 34% over the six months ended June 30, 2025.
◦DecisionDx-Melanoma test reports delivered in the six months ended June 30, 2026, were 20,301, compared to 18,602 for the same period in 2025.
◦TissueCypher Barrett’s Esophagus test reports delivered in the six months ended June 30, 2026, were 26,733, compared to 16,602 for the same period in 2025.
Additional tests:
◦DecisionDx-SCC test reports delivered in the six months ended June 30, 2026, were 7,713, compared to 9,137 for the same period in 2025.
◦MyPath Melanoma test reports delivered in the six months ended June 30, 2026, were 2,034, compared to 2,092 for the same period in 2025.
◦DecisionDx-UM test reports delivered in the six months ended June 30, 2026, were 974, compared to 938 for the same period in 2025.

•Gross margin for the six months ended June 30, 2026, was 74%, and Adjusted Gross Margin was 77%, compared to 63% and 81%, respectively, for the same period in 2025.
•Net loss, which includes non-cash stock-based compensation expense of $21.4 million, was $16.6 million, compared to net loss of $21.3 million for the same period in 2025.
•Net loss per share and Adjusted Net Loss per Share, Basic and Diluted, was $0.55, compared to net loss per share and Adjusted Net Loss per Share, Basic and Diluted, of $0.74 and $0.04, respectively, for the same period in 2025.
•Adjusted EBITDA was $7.3 million, compared to $23.4 million for the same period in 2025.

•Net cash used in operations was $6.9 million, compared to $14.8 million net cash provided by operations for the same period in 2025.
Cash, Cash Equivalents and Marketable Investment Securities
As of Jun. 30, 2026, the Company’s cash, cash equivalents and marketable investment securities totaled $266.8 million.
2026 Outlook
Castle Biosciences is raising its guidance for anticipated total revenue in 2026. The Company now anticipates generating between $365-375 million in total revenue in 2026, compared to the previously provided guidance of between $345-355 million. Further, the Company expects to achieve positive Adjusted EBITDA for the third quarter, the fourth quarter and the full year 2026.

Second Quarter and Recent Accomplishments and Highlights

Dermatology – Skin Cancer
•The Company announced the publication of a prospective, multicenter study in Dermatology and Therapy demonstrating that DecisionDx-Melanoma’s integrated sentinel lymph node biopsy test result (i31-SLNB) outperforms the Melanoma Institute Australia (MIA) nomogram in identifying patients at low and high risk of SLN positivity, supporting more informed SLNB decision-making for patients with cutaneous melanoma (CM). This is the second multicenter study showing that the i31-SLNB result outperforms the MIA nomogram in assessing SLN positivity risk. See the Company’s news release from June 25, 2026, for more information.

Dermatology – Atopic Dermatitis
•The Company announced that its AdvanceAD-Tx test has received assay approval from the New York State Department of Health (NYSDOH). With this approval, Castle has New York State approval for all tests within its dermatology and ophthalmology portfolios, its TissueCypher test within gastroenterology and its clinical laboratories in Phoenix and Pittsburgh. See the Company’s news release from July 14, 2026, for more information.
•The Company announced that its AdvanceAD-Tx test was selected as the winner of the "Genomics Innovation Award" in the 10th annual MedTech Breakthrough Awards program, which recognizes companies driving meaningful progress and improving patient care across the global health and medical technology industry. AdvanceAD-Tx is Castle’s clinically validated gene expression profile (GEP) test designed to guide systemic treatment decision making in patients 12 and older with moderate-to-severe atopic dermatitis (AD). This marks the fifth MedTech Breakthrough Award that Castle has earned for its innovative testing solutions. See the Company’s news release from May 12, 2026, for more information.

Pipeline Initiatives
•In June 2026, the first patient was enrolled in DETECT-AD, a multicenter prospective clinical study being conducted through Castle’s collaboration with SciBase, a global medical technology company, specializing in early detection and prevention in dermatology. The study will investigate the ability of Electrical Impedance Spectroscopy (EIS) to predict the onset of flares in patients with AD, with the goal of enabling proactive interventions and improving patient quality of life.

Corporate
•The Company announced that Frank Stokes, its chief financial officer, has been named a 2026 CFO Awards honoree by the Houston Business Journal. Stokes is among 22 chief financial officers from across the Greater Houston area recognized for their financial leadership and contributions to their organizations’ success. See the Company’s news release from June 23, 2026, for more information.

Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Thursday, July 30, 2026, at 4:30 p.m. Eastern time to discuss its second quarter 2026 results and provide a corporate update.

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until August 20, 2026.
There will be a brief Question & Answer session following management commentary.

(Press release, Castle Biosciences, JUL 30, 2026, View Source [SID1234669528])

Pulse Biosciences to Present at Canaccord Genuity’s 46th Annual Growth Conference

On July 30, 2026 Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation (nano-PFA or nsPFA) technology, reported plans to participate in the upcoming Canaccord Genuity 46th Annual Growth Conference in Boston, MA.

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Pulse Biosciences’ Management is scheduled to present on Tuesday, August 11, at 2:30 pm ET. A live and recorded webcast of the fireside chat will be available on the "Events Calendar and Presentations" page of the company’s investor website at View Source

(Press release, Pulse Biosciences, JUL 30, 2026, View Source [SID1234669548])

IMUNON Reports Strong Enrollment Momentum in Phase 3 OVATION 3 Trial of IMNN-001 in Advanced Ovarian Cancer

On July 30, 2026 IMUNON, Inc. (Nasdaq: IMNN) ("IMUNON" or "the Company"), a clinical-stage biotechnology company developing its novel DNA-mediated immunotherapies, reported a progress update on its pivotal Phase 3 OVATION 3 trial of IMNN-001 in patients with newly diagnosed advanced ovarian cancer. Since initiating the trial, the Company has observed rapid site activation and an enrollment rate that is exceeding its forecast. The trial advanced from protocol submission to site activation in approximately 6 months and from protocol approval to first patient randomized in approximately 2 months, a third of the time of the external industry benchmark.

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The currently observed study-level enrollment rate of approximately 0.5 patients per site per month meaningfully exceeds the assumed rate of 0.3 patients per site per month used in the trial plan. That planning assumption was already set at a premium relative to the Company’s OVATION 2 experience and to historical industry ovarian cancer trials, which have generally enrolled at approximately 0.2 patients per site per month. The strong OVATION 3 enrollment is supported by highly promising clinical and biomarker data, most notably the overall survival (OS) evidence from the large, randomized Phase 2 OVATION 2 study and a high rate of conversion from pre-screening to randomization underscores strong interest in the trial by investigators and patients. More than 70% of sites are currently meeting or exceeding the assumed average enrollment rate of 0.3 patients per month. The Company now projects enrollment to be completed in the second quarter of 2029. Two pre-planned interim analyses are expected with the goal of early BLA filing for full regulatory approval if they achieve the pre-specified threshold.

"The early momentum we are seeing in OVATION 3 reflects the strength of our clinical data, the quality of our sites and the commitment of the investigators and patients participating in the trial," said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. "We’ve seen enrollment build quarter after quarter, including through the early summer months when trials typically slow down, a trend we view as a strong signal of investigator and patient engagement. The consistent safety profile we’ve now observed across multiple studies further re-enforces our confidence in IMNN-001, uniquely designed to safely exploit the pluripotent capability of IL-12 to recruit the entirety of the patient’s own immune system to fight cancer, as we continue to advance our pivotal Phase 3 OVATION 3 trial."

IMNN-001 has continued to demonstrate a highly favorable safety and tolerability profile, with no observed episodes of cytokine release syndrome, systemic toxicities or serious immune-related adverse events that have historically foiled the use of IL-12 to effectively treat cancer patients. Safety profiles have been comparable between the two arms of the study (IMNN-001 plus neoadjuvant and adjuvant chemotherapy {N/ACT} versus N/ACT alone), consistent with observations from the Company’s ongoing Phase 2 Minimal Residual Disease (MRD) study. No safety issues have been raised in recent Independent Data Monitoring Committee (IDMC) reviews of either ongoing study.

About the Phase 3 OVATION 3 Trial

The pivotal Phase 3 OVATION 3 trial is evaluating intraperitoneal IMNN-001 at 100 mg/m² in combination with standard-of-care neoadjuvant and adjuvant chemotherapy versus chemotherapy alone in patients with newly diagnosed advanced epithelial ovarian cancer. The trial is enrolling an all-comers population that includes both homologous recombination-deficient and homologous recombination-proficient patients; eligible patients who respond to first-line platinum-based chemotherapy will proceed to PARP inhibitor maintenance according to applicable guidelines and prescribing information. The primary endpoint is overall survival, with secondary endpoints including chemotherapy response score, surgical response score at interval debulking surgery, time to second-line treatment or death, and objective response rate.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local production of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel neoadjuvantly in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

(Press release, IMUNON, JUL 30, 2026, View Source [SID1234669564])